Events

Stryker Medtech - IIb - 36273; Ultrasonic surgical system generator 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Stryker Medtech K.K. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    22799
  • 사례 시작날짜
    2018-04-11
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Additional information is being added to the instructions for use (ifu) for sonopet® ultrasonic products. ultrasonic surgical aspirator devices use an oscillating tip to cause tissue fragmentation through the delivery of ultrasound energy to target tissue. the potential for tissue dissemination is mitigated, but not completely eliminated, by the use of suction/aspiration. although fda is not aware of reports of dissemination or upstaging of occult uterine malignancies related to ultrasonic surgical aspirators at this time, the agency is recommending that all device manufacturers add a contraindication against use for the removal of uterine fibroids.
  • 조치
    Instructions for use to be updated

Device

Stryker Medtech - IIb - 36273; Ultrasonic surgical system generator
  • 모델명 / 제조번호(시리얼번호)
    Model: Sonopet 110V Console with Foot Pedal and Pole, Sonopet 100V Console with Foot Pedal and Pole, Sonopet 230V Console with Foot Pedal and Pole, Affected:
  • Manufacturer
    Stryker Medtech K.K.

Manufacturer

Stryker Medtech K.K.
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA